BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 1171350 · Received September 22, 2008

    Report

    Report Number
    9610711-2008-00005
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    COLOPLAST MANUFACTURING FRANCE, SAS
    Product Code
    KOD
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICE AND ADDITIONAL INFO HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. AT THIS TIME, NO RESPONSE HAS BEEN REC'D. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFO BE REC'D, AN ADDENDUM TO THIS REPORT WILL BE FILED. UPON REVIEW OF THE LOT HISTORY RECORDS, NO DEFECTS WERE NOTED DURING INSPECTIONS. NO ADDITIONAL REPORTS HAVE BEEN REC'D FOR THIS LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO REC'D, A CATHETER TIP FELL OFF THE CATHETER AND REMAINED INSIDE THE BLADDER UPON CATHETER REMOVAL. THE PT UNDERWENT ENDOSCOPIC PROCEDURE TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLYSIL SILICONE CATHETER SILICONE FOLEY CATHETER KOD COLOPLAST MANUFACTURING FRANCE, SAS AA61161002 7113283

    Patients

    Seq Age Sex Outcome Treatment
    1